FDA 510(k) Application Details - K992153

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

  More FDA Info for this Device
510(K) Number K992153
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT.
BLDG. 15-100
SAN DIEGO, CA 92121-1122 US
Other 510(k) Applications for this Company
Contact HATMUT LOCH
Other 510(k) Applications for this Contact
Regulation Number 888.3350

  More FDA Info for this Regulation Number
Classification Product Code JDI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/25/1999
Decision Date 09/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact